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Case Study: Management Strategies for Hepatitis C and Gaucher Disease Mark Godwin, PharmD, AAHIVP Manager – Clinical Pharmacy Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Agenda As payers continue to be challenged with the increasing costs of specialty medications, various management tools are implemented to maintain an affordable benefit offering for employers and individuals. This session builds on the previous discussion and provides a deep dive into one payer’s management strategies for Hepatitis C and Gaucher Disease. • • • • • Highlight the different challenges associated with managing specialty medications covered under the pharmacy versus the medical benefit Explain the current prior authorization program in place for Hepatitis C Discuss specialty pharmacy engagement/management programs for Hepatitis C Outline the product preferencing strategy implemented for enzyme replacement therapy indicated for the treatment of Gaucher Disease Discuss pull-through efforts as well as program results 2 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Hepatitis C Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Hepatitis C in the Headlines 4 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Condition Overview Hepatitis C Virus (HCV) is a chronic infection that causes severe liver disease and is the leading cause for liver transplants. HEPATITIS C OVERVIEW As a contagious liver disease, it is spread primarily through contact with blood infected with the Hepatitis C Virus. • Top 6 class by spend under pharmacy benefit • Estimated 3.2 million have Hepatitis C, most are unaware • Each year 17,000 Americans become infected POPULATION • Most common in those born 1945-1965 • 31% of UHC’s membership is at risk GENOTYPES Are identified by lab tests. They help determine therapy, length of treatment, and predicting therapy response. • Genotype 1 is most common in U.S. accounting for 75% • Genotypes 2-3 are less common (10-15%) • Other genotypes are rare in the U.S. 1. Hepatitis C Fact Sheet. Centers for Disease Control and Prevention Department of Health and Human Services. June 2010. 2. Hepatitis C Genotypes and Quasispecies. U.S. Department of Veterans Affairs. Referenced Feb. 2014. 5 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. The scope of Hepatitis C 3.2 million persons are infected with Hepatitis C (HCV) in the U.S. and many don’t know they have the disease.1 Left undetected, HCV can result in costly, long-term health problems: Chart source: Centers for Disease Control and Prevention. Hepatitis C Information for Health Professionals. Updated May 7, 2013. Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Who has Hepatitis C? Each year 17,000 Americans become infected. Currently, 31% of UnitedHealthcare’s population are baby boomers. • Adults born between 1945 and 1965 are 5 times more likely to be infected • 3 out of every 4 people with HCV were born between these years • Screening is now recommended for all adults born during this time Chart source: Centers for Disease Control and Prevention. Hepatitis C Information for Health Professionals. Updated May 7, 2013. 7 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Impact of New Therapies After much anticipation for these new more effective therapies, drug use has sharply increased since their launch. 8 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Progression of Treatment Options LAUNCH MEDICATION NAME TOTAL COST OF THERAPY1 CURE RATE $20-40k 44% $50-70k 72% $108-168k 80-100% $63-189k >95% NA >95% Dual therapy 2001-2011 2011-2013 2013 • Peg-interferon (injection) • ribavirin (oral) Incivek2 or Victrelis Added to dual therapy Sovaldi or Olysio Replaces Victrelis Added to dual therapy 2014 Harvoni & Viekira Pak 2015+ Daclatasvir, BMS-791325, GS-9669, MK-8742, MK-5172 1. 2. Replaces Sovaldi / Olysio Total cost per therapy depends on length of therapy and regimen. Current totals based on one-time treatment and not recurring annual costs. Incivek was withdrawn from the market Oct. 2014. 9 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Hepatitis C Drug Pipeline Timeline Nov. 28, 2013: Olysio (Janssen) launched 2013 Dec. 10, 2013: Sovaldi (Gilead) launched December 2014 Viekira Pak (AbbVie) launched 2014 October 2014 Harvoni (Gilead) launched Mid-2016: grazoprevir / elbasvir (Merck)* 2015 2016+ Q3 2015: daclatasvir / asunaprevir / BMS-791325 (BMS) * Merck announced 1/12/2015 that it plans to file an FDA application in the first half of 2015 for a single tablet combining the NS3/4A protease inhibitor grazoprevir (MK5172) and the NS5A inhibitor elbasvir (MK8742) which will expedite the approval timeline. 10 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. 2017: alisporivir (Novartis) Current Management Strategies Managing the class as a whole helps identify program and cost savings opportunities Benefit Design Utilization Management Therapy Assessment First Fill Consults Clinical Management Program 11 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Hepatitis C Management Prior Authorization with Medical Necessity Staying current with rapidly changing treatments is key to controlling costs. With industry-leading coverage criteria, we’ve been at the forefront of managing Hepatitis C. 2014 2014 APR AUG Medical necessity criteria implemented to prioritize coverage based on clinical interpretation. Revisions published to Guidance Document supports how we prioritized coverage in our criteria implemented in April 2014. When and whom to treat highest priority: • Advanced fibrosis and compensated cirrhosis (F3/F4) • Liver transplant recipients • Severe extra hepatic hepatitis C Guidance document from American Association for the Study of Liver Diseases and Infectious Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. OptumRx Specialty Pharmacy Therapy Assessment Hepatitis C Members One Month Supply • • • • Genotype Capture Receive a therapy assessment during their first fill with OptumRx Treatment Based on Clinical Evidence Combination Therapy Review Duration of Treatment Claims Database Check Tailor Refills and Notify Prescriber The processes outlined above are specific to OptumRx. Processes may vary, depending on specialty pharmacy. 13 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Prior Authorization Initiation OptumRx Specialty Pharmacy Dedicated Support for Hep C Members Hepatitis C members receive a clinical consultation during their first fill with OptumRx and can continue to have one-on-one conversations through our Clinical Management Program. Filling prior to OptumRx Adherence Combination Therapy Side Effects High Risk Lifestyle Financial Impact Prescriber Engagement Clinical Management Program • Personalized, one-on-one support • Evaluates all aspects of a member’s health • Member contacted on regular schedule based on their needs. The processes outlined above are specific to OptumRx. Processes may vary, depending on specialty pharmacy. 14 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Moving Forward We will continue to manage the use and cost of Hepatitis C and encourage your clients to leverage these strategies. Benefit Design Utilization Management Therapy Assessment First Fill Consults Clinical Management Program Constant Monitoring 15 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Gaucher Disease Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Enzyme Deficiency Enzyme deficiency includes a class of diseases where enzymes needed for metabolism are missing. Examples of enzyme deficiencies include Gaucher Disease and lysosomal storage disorders. TREND FACTORS • 97.5% of total drug costs were under the medical benefit in 2013 • Patients of all ages can be affected • There are only a few drugs available in this category • Although it is very rare, the conditions are very costly for members and clients Average annual cost of drug therapy1 $154K SMARTER SOLUTIONS Prior Authorization Ensures appropriate diagnosis, drug therapy and duration Medical Necessity To verify that members are receiving the necessary treatments with the lowest-cost medications and care centers Preferred Products Direct use to lower-cost option when clinically appropriate We have already implemented preferred product strategies for Gaucher Disease and looking to expand to other conditions. 1. Approximate average AWP drug cost per patient per year for Legacy Fully Insured business – calendar year 2013. Source: Information based on UnitedHealthcare drug report from fully insured and self-funded commercial membership who have UnitedHealthcare medical benefits. Fiscal year 2012. 17 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Gaucher Disease – Medical Necessity and Preferred Product Why were these medications chosen for medical necessity? The specialty medications used for the treatment of Gaucher disease are high-cost. Prior authorization with medical necessity allows us to guide use of enzyme replacement medications before coverage is provided. Why was VPRIV chosen as the preferred enzyme replacement product? Although only a small number of UnitedHealthcare and Oxford members currently use the enzyme replacement medications used to treat Gaucher disease, use of these medications has a significant impact on pharmacy cost trends with the average cost of therapy ranging from $250,000 to $350,000 per patient, depending on the dose. UnitedHealth Group’s National Pharmacy and Therapeutics Committee has reviewed the medications in this class and deemed them clinically comparable since they provide similar therapeutic outcomes and responses. As such, UnitedHealthcare was able to negotiate a competitive rate for VPRIV that will help provide an affordable option for members while keeping costs down for our clients. 18 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group. Gaucher Disease – Member and Physician Outreach Specialty Pharmacy Outreach: • UnitedHealthcare’s network of specialty pharmacies engaged members and their physicians starting 3 months prior to the preferred product effective date • Bi-weekly calls between UnitedHealthcare and the specialty pharmacy teams allowed immediate resolution for any concerns Physician and Professional Society Outreach: • UnitedHealthcare met with key opinion leaders within the Gaucher community 6 months prior to the preferred product effective date • UnitedHealthcare met with the National Gaucher Foundation on numerous occasions in the months leading up to the preferred product requirement Outreach and Engagement were key to success: • 35% of existing Cerezyme users switched to VPRIV • With pro-active engagement member disruption was essentially eliminated 19 Proprietary information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group.